Vegicaps Soft capsules

Our global facilities

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Advanced softgel solutions to pharmaceutical formulation challenges

About Catalent
Our technical expertise and global experience enable our customers to focus on their core strengths. In an industry where innovation, time-to-market, and supply chain reliability are critical, no other company helps overcome formulation hurdles, achieves approval milestones, and meets market needs more effectively than Catalent. With experience in more than 100 countries, extensive knowledge of the pharmaceutical, biotechnology and consumer healthcare markets, and a global facility network that spans ve continents, Catalent is well positioned to serve you, wherever you do business.
Vegicaps is a registered trademark of Catalent Pharma Solutions. Copyright 2007 Catalent Pharma Solutions. All rights reserved. Lit. No. OT-VEG-BR (11/07) Printed by Catalent Pharma Solutions, Moorestown, NJ.

Catalent Pharma Solutions 14 Schoolhouse Road Somerset, NJ 08873 USA T (866) 720 3148 F (732) 537 6480 www.catalent.com sales@catalent.com

Vegicaps Soft capsules: the breakthrough softgel technology from Catalent

Vegicaps Soft capsules from Catalent offer a novel approach to the encapsulation of liquid ll formulations that previously could not be encapsulated using conventional gelatin-based softgels. This breakthrough from a leader in drug delivery presents opportunities for both existing and future products.

Vegicaps Soft capsulesalready widely used in health and nutritional productsnow available for pharmaceutical applications

A patented innovation that has an established track record in the health and nutritional industry is now available for pharmaceutical applications with the opening of state-ofthe-art laboratories and cGMP manufacturing facility in St. Petersburg, Florida.
The development of a vegetable-based gel mass suitable for pharmaceutical formulations involves extensive testing, including the measurement of shell materials on the rheometer. The development of Vegicaps Soft capsules for pharmaceutical applications represents a signicant advancement in softgel technology that serves both pharmaceutical companies and consumers. For companies, this new enabling technology allows softgels to be considered for an expanded number of Rx and OTC products. For consumers, Vegicaps Soft capsules, already widely used in health and nutritional products, represent the next logical step into the pharmaceutical market.

State-of-the-art facility for product development, preclinical, clinical and commercial manufacturing
Fully equipped laboratories for product development, including: Material characterization Controlled stress/controlled rate rheology Analysis of the physical properties of gels and lms Adsorption/desorption properties Benchtop and closed vessel ll material preparation Shell formulation and color development Dissolution/disintegration Microscopy Moisture analysis cGMP area for clinical and commercial manufacturing: Encapsulation equipment - Utilizing state-of-the art melt-on-demand and low pressure extrusion technology Various multipurpose (heating, cooling, pressure, vacuum, low and high sheer-agitation compatibilities), closed mixing reactors for preparing of capsule ll - Batch size of 100 kg to 2,000 kg Specialized gel melter with contra-rotation mixing - Batch size of 280 kg to 500 kg Versatile closed-vessel laboratory processor to manufacture ll systems for small-scale encapsulation runs.

Key enabling features of Vegicaps Soft capsules allow encapsulation of:

Heated lled materials for highly viscous or semi-solid ll systems Chemically aggressive ll systems with high alkalinity API or excipients that cross-link conventional gelatin softgels

Vegicaps Soft capsule technology is patent protected

US Patent Numbers: 6,340,473 6,582,727 6,884,060 Vegicaps Soft capsules are the result of years of research and development and a multimillion-dollar investment.

How Vegicaps Soft capsules are made

The science behind a softgel evolution
Vegicaps Soft capsules employ a unique form of our patented rotary-die encapsulation process. The primary shell ingredients are plant-derived with worldwide regulatory acceptance. The supply of material is stable, ensuring continuity for even the most demanding volumes. The manufacturing process used for Vegicaps Soft capsules is identical to that of traditional softgels. The steps include: Preparation of ll material Preparation of the shell mass Shell-lm formation Encapsulation Drying The combination of shell matrix, plasticizer and acidity regulator used in Vegicaps Soft capsules works exceptionally well with many ll formulations. The plasticizers used in traditional softgels also work equally well with Vegicaps Soft capsules. Vegicaps Soft capsules provide all the same benets as conventional softgels wide selection of shapes, sizes and colors, plus more with the elimination of shell odor and a more neutral shell color.

Preparation of the ll material

A wide variety of lls can be prepared utilizing multipurpose closed mixing reactors. Types of ll material include solutions, suspensions, highly viscous liquids and semi-solids.

Preparation of the shell mass

The shell-forming composition is prepared in a closed, evacuated and temperature-controlled vessel. The mass is stirred and heated until a homogeneous, molten blend is achieved. That blend is then transferred to a holding container and staged, unheated, prior to encapsulation.

Shell-lm formation
The shell mass is heated and melted as required. The molten material is pressure fed to extrusion dies via a metering pump, producing a lm as the mass is extruded onto a casting drum. The lm thickness is precisely controlled using electronic metering and positioning of the extrusion dies.

Encapsulation
The resulting lms are peeled from the casting drums and fed between a pair of rotating dies. A form, ll, seal process is used that is identical to the one used to prepare conventional softgels. Capsule seals are formed through a combination of heat and pressure. The freshly formed Vegicaps are then transferred to a drying device.

Drying
The rst stagea tumble dryer removes a signicant portion of the water present in the shell. The semi-dried capsules are spread onto trays to complete drying. Dried capsules are washed and inspected before bulk packaging.

Vegicaps Soft capsules expand the range of ll formulations for the softgel
A unique composition with unique product features
The Vegicaps Soft capsules shell formula includes: Modied starch Carrageenan (extracted from red seaweed) Disodium phosphate Glycerol and/or sorbitol Puried water

Vegicaps Soft capsules represent an extension to softgel technology

The development of Vegicaps Soft capsules for pharmaceutical applications is the result of years of research and a multimillion-dollar investment. To date, formulations for Vegicaps Soft capsules have successfully undergone shell/ll interaction and stability studies in which they have demonstrated excellent physical and chemical stability. Vegicaps Soft capsules have been proven effective for encapsulation of a variety of ll formulations that were not previously capable of being encapsulated into conventional softgels.

Product enabling features

A wide range of ll-formulation options, including: Hydrophilic Lipophilic Microemulsion preconcentrates Semi-solids or highly viscous liquids Immediate or modied release High levels of surfactants High drug concentrations and drug salts Excellent stabilitythe shell is not degraded by chemically aggressive ingredients and does not undergo cross-linking. Capsules are stable with highly alkaline lls up to pH 12.1 Eliminates cross-linking of capsule shell for lls containing API or excipients that have aldehyde or ketone groups Vegicaps Soft capsules can withstand elevated lling temperatures without adversely affecting the capsule quality, allowing highly viscous liquids and semi-solids to be successfully encapsulated up to 65C.

Vegicaps Soft capsules offer a solution to todays pharmaceutical development challenges

Application to a wide range of ll formulations Improved chemical and physical stability for corrosive lls Utilizes plant-derived ingredients with worldwide regulatory acceptance
Vegicaps Soft capsules represent a breakthrough solution to pharmaceutical formulation challenges.

Just one more way Catalent can help your product perform
The advantages and benets of Vegicaps Soft capsules are numerous. This exciting new technology can help improve a products acceptance and commercial performance. With expertise that spans the entire product life cycledrug discovery and development to delivery, manufacturing and packagingCatalent offers the industrys most complete range of services to help your business succeed.